Catalog Number

12470-02

Brand Name

pjur Woman Aqua

Version/Model Number

pjur Woman Aqua 100 ml - USA

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K010199,K010199,K010199

Product Code

NUC

Product Code Name

Lubricant, Personal

Public Device Record Key

3285e318-4fbd-4dc2-af95-50180d63ac4b

Public Version Date

August 31, 2022

Public Version Number

6

DI Record Publish Date

January 25, 2017

Package DI Number

40827160112125

Quantity per Package

12

Contains DI Package

10827160112124

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case